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GRUPO DE ENZIMAS ERBA. - COFEPRIS Registration 660R2021 SSA

Access comprehensive regulatory information for GRUPO DE ENZIMAS ERBA. (GROUP OF ERBA ENZYMES.) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 660R2021 SSA and manufactured by HRD HIGHRESOLUTION DIAGNOSTICS, S.A. DEC.V.. The device was registered on April 16, 2021.

This page provides complete registration details including product type (III. DIAGNOSTIC AGENTS), manufacturer information, and regulatory compliance data from the official Mexico COFEPRIS medical device database. Pure Global AI offers free access to Mexico's complete medical device registry with bilingual Spanish/English support, helping global MedTech companies navigate COFEPRIS regulations efficiently.

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COFEPRIS Official Data
Clase I
660R2021 SSA
GRUPO DE ENZIMAS ERBA.
COFEPRIS Analysis ID: 660R2021 SSA
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Product Use / Uso del Producto
Spanish

LOS REACTIVOS GRUPO DE ENZIMAS ERBAESTÁN DESTINADAS AL DIAGNÓSTICO INVITRO PARA LA DETERMINACIÓNCUANTITATIVA DE ALFA AMILASA, ALANINAAMINOTRANSFERASA, ASPARTATOAMINOTRANSFERASA, LIPASA Y GAMMAGLUTAMILTRANSFERASA,ENSUERO,PLASMAHUMANO U ORINA, EN LOS EQUIPOS DEQUÍMICA CLÍNICA MARCA ERBA. PARA USOEXCLUSIVODELABORATORIOCLÍNICOYDEGABINETE.

English

THE REAGENTS GROUP OF ENZYMES ERBA ARE INTENDED FOR THE DIAGNOSIS INVITRO FOR THE QUANTITATIVE DETERMINATION OF ALPHA AMYLASE, ALANINE AMINOTRANSFERASE, ASPARTATE AMINOTRANSFERASE, LIPASE AND GAMMAGLUTAMYLTRANSFERASE, SERUM, HUMAN PLASMA OR URINE, IN THE EQUIPMENT OFCLINICAL CHEMISTRY BRAND ERBA. FOR EXCLUSIVE use of clinical laboratory and cabinet.

Device Classification
Risk Class / Clase de Riesgo
Clase I
Product Type (Spanish)
III. AGENTES DE DIAGNÓSTICO
Product Type (English)
III. DIAGNOSTIC AGENTS
Trade Name (Spanish)
REACTIVODEDIAGNÓSTICOINVITROPARAENZIMAS.
Trade Name (English)
REACTIVODEDIAGNÓSTICOINVITROPARAENZIMAS.
Registration Information
Analysis ID
660R2021 SSA
Registration Date
April 16, 2021
Manufacturer / Fabricante
Name (English)
HRD HIGHRESOLUTION DIAGNOSTICS, S.A. DEC.V.